DEVICE: CapSure Sense MRI™ SureScan™ (00643169448858)

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Device Identifier (DI) Information

CapSure Sense MRI™ SureScan™
407452

MEDTRONIC, INC.
00643169448858
GS1
1
LEAD 407452 MRI US BI MVC RCMRCD
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Device Characteristics

MR Conditional
No
No
Yes
Yes
No
No
Yes
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Endocardial pacing lead A sterile, implantable flexible wire with an electrode, insulated with non-conductive material except at its ends, which serves as an electrical conductor to transmit pacing impulses from an implanted pulse generator to the heart; it is not intended to conduct defibrillation impulses. It may also transmit electrical responses from the heart back to the pacemaker. The electrode end is normally placed through a vein to contact the wall of one of the heart's chambers (endocardium), and the other end is connected to the pacemaker. It is typically impregnated with a steroid (e.g., dexamethasone) intended to elute into the tissues to reduce inflammation.
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FDA Product Code

[?]
Product Code Product Code Name
DTB permanent pacemaker Electrode
NVY Permanent defibrillator electrodes
NVN Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: exactly 77 Degrees Fahrenheit
Handling Environment Temperature: between 59 and 86 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
Length: 52.0 Centimeter
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Device Status

In Commercial Distribution
February 05, 2017

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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
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